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April 11, 2023

Paper Proposes Further Actions to Harmonize Testing of Nanomaterials for EU Regulatory Requirements

Lynn L. Bergeson Carla N. Hutton

On April 6, 2023, NanoHarmony announced publication of a paper in Regulatory Toxicology and Pharmacology entitled “Towards harmonisation of testing of nanomaterials for EU regulatory requirements on chemical safety — A proposal for further actions.” The paper provides an overview of the information requirements across different European Union (EU) regulatory areas. For each information requirement, experts identified potential needs for further action to accommodate guidance and test guidelines to nanomaterials. According to the abstract, 11 different needs for action were identified, capturing 22 information requirements that are specific to nanomaterials and relevant to multiple regulatory areas. These were further reduced to three overarching issues:

  • Resolve issues around nanomaterial dispersion stability and dosing in toxicity testing, in particular for human health endpoints;
  • Further develop tests or guidance on degradation and transformation of organic nanomaterials or nanomaterials with organic components; and
  • Further develop tests and guidance to measure (a)cellular reactivity of nanomaterials.

The abstract states that efforts to address these issues will result in better fit-for-purpose test methods for regulatory compliance. According to the abstract, “[t]he results of the study accentuate the need for a structural process of identification of information needs and knowledge generation, preferably as part of risk governance and closely connected to technological innovation policy.”